http://clinicaltrials.gov/ct2/show/N...&sel_rss=mod14

Repeated-Dose Oral N-acetylcysteine for the Treatment of Parkinson's Disease


This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
University of Minnesota - Clinical and Translational Science Institute
Collaborator:
Parkinson's Disease Society of the United Kingdom
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT02212678
First received: August 4, 2014
Last updated: August 7, 2014
Last verified: August 2014
History of Changes

Full Text View
Tabular View
No Study Results Posted
Disclaimer
How to Read a Study Record

Purpose

The investigators are interested in evaluating the use of oral N-acetylcysteine (NAC) as therapy for Parkinson's Disease (PD) and measuring changes in brain and blood chemistry.

Condition Intervention Phase
Parkinson Disease
Drug: N-acetylcysteine capsule
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Repeated-Dose Oral N-acetylcysteine for the Treatment of Parkinson's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: Parkinson disease Perry syndrome
MedlinePlus related topics: Parkinson's Disease
Drug Information available for: Acetylcysteine
U.S. FDA Resources

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:

GSH brain levels [ Time Frame: pre-dose and after approximately 28 days of treatment ] [ Designated as safety issue: No ]
GSH levels in brain of all subjects at baseline and post-NAC dosing as measured by MRS


Secondary Outcome Measures:

NAC clearance [ Time Frame: 8 hours after NAC dosing ] [ Designated as safety issue: No ]
NAC concentrations will be measured prior to and after dosing to estimate NAC clearance

GSH and GSH redox blood levels [ Time Frame: predose and after approximately 28 days of dosing ] [ Designated as safety issue: No ]
GSH and GSH redox measurements will be made prior to dosing and after approximately 28 days of dosing

NAC volume of distribution [ Time Frame: over 8 hrs after dosing ] [ Designated as safety issue: No ]
NAC concentrations will be measured prior to and after dosing to estimate NAC volume of distribution


Estimated Enrollment: 9
Study Start Date: September 2014
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: N-acetylcysteine
Subjects will be provided 6000 mg/day of N-acetylcysteine (capsule) to be divided into 2 equal daily doses and taken orally for approximately 28 days
Drug: N-acetylcysteine capsule
N-acetylcysteine capsule
Other Name: NAC

Detailed Description:

The investigators are interested in evaluating the use of oral N-acetylcysteine (NAC) as therapy for Parkinson's Disease (PD) and measuring changes in brain and blood chemistry. The investigators' hypothesis is that repeated oral dosing of NAC will result in increased brain and red blood cell GSH concentrations in individuals with Parkinson's disease (PD) and healthy controls. The specific aims are to 1.) measure plasma and blood (red blood cell) glutathione (GSH) and ratio of reduced GSH to oxidized glutathione (GSSG) in individuals with PD and healthy controls at baseline and after four weeks of repeated high doses of oral NAC (6000 mg/day) and 2) measure cortical GSH levels (as ascertained through MRS) in those with PD and healthy controls at baseline and four weeks during repeated high doses of oral NAC (6000 mg/day) simultaneously with Aim 1. This study will combine information from a medical history, a physical examination, and disease rating scales with results obtained using Magnetic Resonance Spectroscopy (MRS) brain scans and pharmacokinetic studies from blood samples. This research will require 2 visits, one at baseline and one after approximately 28 days of therapy. Participants will provide their medical history during the first visit, and undergo a physical examination and rating scale each visit (duration: 1 hour). The first visit including the brain scans and blood collection will require approximately 3 hours of time. The brain scan and pharmacokinetic studies for the second visit will require approximately 8 hours of time. In total the second visit will take roughly 9 hours.
Eligibility

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

All participants must be 18 years or older
All enrollees must understand and cooperate with requirements of the study in the opinion of the investigators and must be able to provide written informed consent
Individuals with medically stable Parkinson's disease (in the opinion of the investigator)
All participants must not have taken antioxidants NAC, glutathione, coenzyme Q-10, vitamin C, or vitamin E for 3 weeks prior to the study
Absence of dementia in all subjects

Exclusion Criteria:

Inability to undergo MRI scanning without sedation and other MRI counterindications, such as metal in the body (see section 7.3)
Medically unstable conditions as determined by the investigators
Pregnant or lactating or those women of child-bearing age that are not using acceptable forms of contraception
Diagnosis of asthma that is presently being treated with ANY medication, or past history of asthma/bronchospasm resulting in an emergency room visit, hospitalization or treatment
Unable to adhere to study protocol for whatever reason

Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02212678

Contacts
Contact: Lisa D Coles, PhD 612-624-1861 durh0016@umn.edu

Locations
United States, Minnesota
University of Minnesota Not yet recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Lisa D Coles, PhD 612-624-1861 durh0016@umn.edu
Principal Investigator: Paul Tuite, MD
Principal Investigator: Lisa Coles, PhD
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Parkinson's Disease Society of the United Kingdom
Investigators
Principal Investigator: Paul Tuite, MD University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Lisa Coles, PhD University of Minnesota - Clinical and Translational Science Institute
More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02212678 History of Changes
Other Study ID Numbers: 1406M51207, 123269
Study First Received: August 4, 2014
Last Updated: August 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes